Appeal of an NOC Proceeding; 2009 FCA 212; levofloxacin; June 22, 2009

The Court of Appeal overturned the decision of the applications judge in issuing a prohibition order and sent it back for reconsideration. A summary of the decision below is found here.

Previously, another generic company, Novopharm, had sent a Notice of Allegation (NOA) regarding the same patent. That allegation had related to invalidity and was found to be justified. No appeal could be taken from that decision as it was rendered moot by the issuance of an NOC to Novopharm. Janssen then sued Novopharm for patent infringement and Novopharm counterclaimed with allegations of invalidity. At trial, the patent was found to be valid and infringed. This decision was upheld on appeal.

Apotex then sent its NOA. The applications judge granted prohibition partially on the basis of abuse of process, holding that Apotex should be bound by the trial decision in the Court of Appeal in Novopharm. The applications judge held that there was no basis for allowing Apotex to contest the validity of the patent unless it has better evidence or more appropriate legal argument.

Although there were many grounds of appeal, the Court of Appeal only considered the abuse of process argument. The Court found the applications judge’s decision in this regard to be in error as there was nothing in its previous decision in sanofi-aventis that supported the judge’s conclusion. Because there was no abuse of process on the part of Apotex, the judge was required to assess the evidence put before him by both parties independently of the findings made by the Court in the Novopharm trial.

The Court of Appeal then found that all of the judge’s reasons were tainted by his misunderstanding of the principles set out in sanofi-aventis. Thus, the matter was sent back to the applications judge for consideration on the basis that there was no abuse of process. The judge was also instructed to assess the evidence independently of the findings made by the Court in the Novopharm trial.

The full text of the decision can be found at:

http://decisions.fca-caf.gc.ca/en/2009/2009fca212/2009fca212.html